Desmopressin Acetate 0.2 mg Tablets, Fasting

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT00835211
First received: January 30, 2009
Last updated: September 1, 2009
Last verified: September 2009
  Purpose

The objective of this study was to compare the single-dose relative bioavailability of TEVA and Aventis Pharmaceuticals (DDAVP®) 0.2 mg desmopressin acetate tablets following a 0.8 mg dose under fasting conditions.


Condition Intervention Phase
Healthy
Drug: Desmopressin Acetate 0.2 mg Tablets
Drug: DDAVP® 0.2 mg Tablets
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of TEVA and Aventis Pharmaceuticals (DDAVP®) 0.2 mg Desmopressin Acetate Tablets in Healthy Adult Subjects Following a 0.8 mg Dose Under Fasting Conditions

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceuticals USA:

Primary Outcome Measures:
  • Cmax - Maximum Observed Concentration [ Time Frame: Blood samples collected over 12 hour period ] [ Designated as safety issue: No ]
  • AUCinf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) [ Time Frame: Blood samples collected over 12 hour period ] [ Designated as safety issue: No ]
  • AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) [ Time Frame: Blood samples collected over 12 hour period ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: July 2003
Study Completion Date: August 2003
Primary Completion Date: August 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Desmopressin Acetate 0.2 mg Tablets
4 x 0.2 mg, single-dose fasting
Active Comparator: 2 Drug: DDAVP® 0.2 mg Tablets
4 x 0.2 mg, single-dose fasting

Detailed Description:

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy adult non-smoker (for at least 3 months) or light smoking (less than 10 cigarettes per day for at least 3 months) male or female subjects, 18-55 years of age;
  • Weighing at least 60 kg for males and 52 kg for females;
  • Subjects who had a body mass index (BMI) less than 30;
  • Medically healthy subjects with clinically normal laboratory profiles and ECGs;

Females of childbearing potential should have either been sexually inactive (abstinent) for 14 days prior to the first dose and throughout the study or have been using one of the following acceptable birth control methods:

  • surgically sterile (tubal ligation, hysterectomy, bilateral oophorectomy) 6 months minimum. Proof was required for the hysterectomy and oophorectomy;
  • IUD in place for at least 3 months;
  • barrier methods (condom, diaphragm) with spermicide for at least 14 days prior to the first dose and throughout the study;
  • surgical sterilization of the partner (vasectomy for 6 months minimum);
  • hormonal contraceptives for at least 3 months prior to the first dose of the study.

Other birth control methods were deemed acceptable. Postmenopausal women with amenorrhea for at least 2 years were eligible.

  • Voluntarily consent to participate in the study.

Exclusion Criteria:

  • Female subjects who were pregnant or lactating.
  • Subjects who had been on a special diet (for whatever reason) during the 28 days prior to the first dose and throughout the study.
  • Any clinically significant illness within 4 weeks prior to dosing.
  • Subjects with any medical condition requiring regular treatment with prescription drugs.
  • The use of any pharmacological agents known to significantly induce or inhibit drug-metabolizing enzymes within 30 days prior to the first dose.
  • Subjects who, through completion of the study, would have donated in excess of: 500 mL of blood and/or plasma in 14 days; 1500 mL of blood and/or plasma in 180 days; 2500 mL of blood and/or plasma in 1 year.
  • Subjects who had donated plasma within 30 days prior to the first dose.
  • Subjects who ahd participated in another clinical trial within 30 days prior to the first dose.
  • Subjects who did not tolerate venipuncture.
  • History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease.

In addition, the history or presence of:

  • hypersensitivity or idiosyncratic reaction to desmopressin or any other synthetic anti-diuretic hormones;
  • type IIB von Willebrand's disease;
  • personal or family bleeding disorder;
  • alcoholism or drug abuse within the past year.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00835211

Locations
Canada, Quebec
MDS Pharma Sercives
St. Laurent, Quebec, Canada, H4R 2N6
Sponsors and Collaborators
Teva Pharmaceuticals USA
Investigators
Principal Investigator: Gaetano Morelli, M.D. MDS Pharma Services
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00835211     History of Changes
Other Study ID Numbers: AA04887
Study First Received: January 30, 2009
Results First Received: June 30, 2009
Last Updated: September 1, 2009
Health Authority: Canada: Ethics Review Committee

Keywords provided by Teva Pharmaceuticals USA:
Bioequivalence
Healthy Subjects

Additional relevant MeSH terms:
Deamino Arginine Vasopressin
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 24, 2014